Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SC1 Handheld Ultrasound Imaging System (Model: SC1)

K-Number: K210468 · 2021-07-23

ApplicantFcu Co., Ltd.
Decision Date2021-07-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SC1 Handheld Ultrasound Imaging System (Model: SC1) is a medical device manufactured by Fcu Co., Ltd.. It received FDA 510(k) clearance on 2021-07-23 under approval number K210468. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SC1 Handheld Ultrasound Imaging System (Model: SC1)?

SC1 Handheld Ultrasound Imaging System (Model: SC1) is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Fcu Co., Ltd.. The 510(k) number is K210468.

When was SC1 Handheld Ultrasound Imaging System (Model: SC1) approved by the FDA?

SC1 Handheld Ultrasound Imaging System (Model: SC1) received FDA 510(k) clearance on 2021-07-23, under approval number K210468.

What company makes SC1 Handheld Ultrasound Imaging System (Model: SC1)?

SC1 Handheld Ultrasound Imaging System (Model: SC1) is manufactured by Fcu Co., Ltd..

What is the FDA product code for SC1 Handheld Ultrasound Imaging System (Model: SC1)?

The FDA product code for SC1 Handheld Ultrasound Imaging System (Model: SC1) is IYO.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41987469 [Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Fcu Co., Ltd.

K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑